56710 Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices 

Privacy 

If contestants choose to provide HHS/ 

CDC with personal information by 

registering or filling out the submission 

form through the Challenge.gov Web 

site, that information is used to respond 

to contestants in matters regarding their 

submission, announcements of entrants, 

finalists, and winners of the contest. 

Information is not collected for 

commercial marketing. Winners are 

permitted to cite that they won this 

contest. 

General Conditions 

HHS/CDC reserves the right to cancel, 

suspend, and/or modify the contest, or 

any part of it, for any reason, at HHS/ 

CDC’s sole discretion. 

Participation in this contest 

constitutes a contestant’s full and 

unconditional agreement to abide by the 

contest’s official rules found at 

www.Challenge.gov. 

Authority: 15 U.S.C. 3719 

Dated: September 9, 2013. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2013–22285 Filed 9–12–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10199 and 

CMS–10266] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by October 15, 2013: 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs 

Attention: CMS Desk Officer Fax 

Number: (202) 395–6974 OR Email: 

OIRA_submission@omb.eop.gov To 

obtain copies of a supporting statement 

and any related forms for the proposed 

collection(s) summarized in this notice, 

you may make your request using one 

of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal Agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Data 

Collection for Medicare Facilities 

Performing Carotid Artery Stenting with 

Embolic Protection in Patients at High 

Risk for Carotid Endarterectomy; Use: 

We provide coverage for carotid artery 

stenting (CAS) with embolic protection 

for patients at high risk for carotid 

endarterectomy and who also have 

symptomatic carotid artery stenosis 

between 50 percent and 70 percent or 

have asymptomatic carotid artery 

stenosis ≥ 80 percent in accordance with 

the Category B IDE clinical trials 

regulation (42 CFR 405.201), a trial 

under the CMS Clinical Trial Policy 

(NCD Manual § 310.1, or in accordance 

with the National Coverage 

Determination on CAS post approval 

studies (Medicare NCD Manual 20.7). 

Accordingly, we consider coverage for 

CAS reasonable and necessary (section 

1862 (A)(1)(a) of the Social Security 

Act). However, evidence for use of CAS 

with embolic protection for patients 

with high risk for carotid 

endarterectomy and who also have 

symptomatic carotid artery stenosis ≥ 70 

percent who are not enrolled in a study 

or trial is less compelling. To encourage 

responsible and appropriate use of CAS 

with embolic protection, we issued a 

Decision Memo for Carotid Artery 

Stenting on March 17, 2005, indicating 

that CAS with embolic protection for 

symptomatic carotid artery stenosis ≥ 70 

percent will be covered only if 

performed in facilities that have been 

determined to be competent in 

performing the evaluation, procedure 

and follow-up necessary to ensure 

optimal patient outcomes. In accordance 

with this criteria, we consider coverage 

for CAS reasonable and necessary 

(section 1862 (A)(1)(a) of the Social 

Security Act). Form Number: CMS– 

10199 (OCN: 0938–1011); Frequency: 

Yearly; Affected Public: Business or 

other for-profit and Not-for-profit 

institutions; Number of Respondents: 

1,000; Total Annual Responses: 1,000; 

Total Annual Hours: 500. (For policy 

questions regarding this collection 

contact Lori Ashby at 410–786–6322.) 

2. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions of 

Participation: Requirements for 

Approval and Reapproval of Transplant 

Centers to Perform Organ Transplants; 

Use: The Conditions of Participation 

and accompanying requirements 

specified in the regulations are used by 

our surveyors as a basis for determining 

whether a transplant center qualifies for 

approval or re-approval under Medicare. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices 56711 

1Patient Protection and Affordable Care Act; Data 

Collection To Support Standards Related to 

Essential Health Benefits; Recognition of Entities for 

the Accreditation of Qualified Health Plans Final 

Rule 77 FR 42658, 42662–42668 (July 20, 2012) (45 

CFR 156.275(c)). 

2Certain authority under the Affordable Care Act 

has been delegated from the Secretary to the 

Administrator of CMS., 76 FR 53903 through 53906, 

(Aug. 30, 2011). 

3Patient Protection and Affordable Care Act; 

Standards Related to Essential Health Benefits, 

Actuarial Value, and Accreditation; Final Rule, 78 

FR 12834, 12854–12855 (February 25, 2013)(45 CFR 

156.275(c)). 

We, along with the healthcare industry, 

believe that the availability to the 

facility of the type of records and 

general content of records is standard 

medical practice and is necessary in 

order to ensure the well-being and 

safety of patients and professional 

treatment accountability. Form Number: 

CMS–10266 (OCN: 0938–1069); 

Frequency: Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 226; Total Annual 

Responses: 528; Total Annual Hours: 

2,523. (For policy questions regarding 

this collection contact Diane Corning at 

410–786–8486.) 

Dated: September 10, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–22329 Filed 9–12–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9953–PN] 

Health Insurance Exchanges; 

Application by the Accreditation 

Association for Ambulatory Health 

Care To Be a Recognized Accrediting 

Entity for the Accreditation of Qualified 

Health Plans 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

receipt of an application from the 

Accreditation Association for 

Ambulatory Health Care (AAAHC) to be 

a recognized accrediting entity for the 

purposes of fulfilling the accreditation 

requirement as part of qualified health 

plan (QHP) certification. Regulations 

require HHS to publish a notice 

identifying the accrediting entity, 

summarizing its analysis of whether the 

accrediting entity meets certain criteria, 

and providing no less than a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on October 15, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–9953–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9953–PN, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9953–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Zimmermann, at (301) 492– 

4396. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Regulations at 45 CFR 156.275 require 

qualified health plan (QHP) issuers to be 

accredited on the basis of local 

performance of its QHPs by an 

accrediting entity recognized by the 

Department of Health and Human 

Services (HHS). In a final rule published 

on July 20, 2012,1 we established the 

first phase of an intended two-phase 

approach to recognize accrediting 

entities and proposed both the National 

Committee for Quality Assurance 

(NCQA) and URAC as recognized 

accrediting entities. On November 23, 

2012, we notified the public that NCQA 

and URAC had both met the 

requirements in the final rule to be 

recognized as an accrediting entity (77 

FR 42662 through 42668) and were 

recognized by the Secretary 2 as 

accrediting entities for the purposes of 

QHP certification. 

On February 25, 2013, we published 

a subsequent final rule title, ‘‘Standards 

Related to Essential Health Benefits, 

Actuarial Value, and Accreditation (78 

FR 1283),’’ 3 which amended 

§ 156.275(c) to establish an application 

and review process to allow additional 


tkelley on DSK3SPTVN1PROD with NOTICES